Haemostatic catheter



2 1958 v. J. ODDO 2,849,002

HAEMOSTATIC CATHETER 1 Filed March 12, 1956 2 Sheets-Sheet 1 INVENTOR. X INCENT J. ODDO FIG. 3 2 w;

ATTORNEY Aug. 26, 1958 v. J. ODDO 9,

HAEMOSTATIC CATHETER Filed March 12, 1956 2 Sheets-Sheet 2 (Q I 22' m xg INVENTOR. g VINCENT J. ODDO United States Patent Ofiiicc 2,849,002 HAEMOSTATIC CATHETER 1 Vincent J. Oddo, Cranston, R. I. Application March 12, 1956, Serial No. 570,758 12 Claims. (Cl. 128-325) My present invention relates to a surgical appliance, and more particularly to a haemostatic catheter.

The present invention constitutes an improvement over my copending application entitled Haemostatic Catheter, filed October 17, 1955, Serial No. 540,674.

The principal object of the present invention is to provide a catheter which can be used for stopping or checking bleeding in certain types of operations. 1

Another object of the present invention is to provide a catheter designed to bring pressure to bear against all the affected parts to check bleeding after a prostatectomy has been performed.

Another object of the present invention is to provide a haemostatic catheter that can also be used as a conventional drainage catheter.

Another object of the present invention is to provide a haemostatic catheter which is simple in construction and easy and economical to manufacture and assemble.

With the above and other objects and advantageous features in view, my invention consists of a novel arrangement of parts, more fully disclosed in the detailed description following, in conjunction with the accompanying drawings, and more specifically defined in the appended claims.

In the drawings:

Fig. l is an enlarged view of the bladder and urethra with the catheter of the present invention in place.

Fig. 2 is a side elevation of the catheter.

Fig. 3 is an enlarged longitudinal section of the distal end with the balloons inflated.

Fig. 4 is a side elevation of another form of catheter embodying my invention.

Fig. 5 is an enlarged view of the distal end with the balloons inflated.

Fig. 6 is a longitudinal section of the portion shown in Fig. 5.

In certain types of operations there is a great deal of postoperative bleeding which is diflicult to check. More particularly, an operation for the removal of the prostate gland results in bleeding in the prostatic bed and the vesical neck. This is true regardless of the technique or method used in removing the gland. A conventional method of attempting to stop the bleeding is by inserting a balloon catheter, inflating the balloon in the bladder and pulling outwardly. This applies some pressure to the lower portion of the bladder and the upper portion of the vesical neck. But there is no pressure on the prostatic bed or the inferior portion of the vesical neck. Therefore the bleeding will usually continue for about one or two days or longer with the result that the patient becomes very weak.

In my copending application herein referred to I have provided a construction designed to provide pressure in the prostatic bed, above and below the vesical neck, and directly on the vesical neck. This was accomplished by joining the two balloons to form a common wall and prevent their separation. Certain difliculties of manu- Patented Aug. 26, 1958 facture present themselves with this construction and the balloons may not be in proper position due to a lack of separation. The present invention provides a catheter construction which is simpler to manufacture and assemble. The balloons of the present invention will be properly spaced and the construction is designed to produce pressure on the prostatic bed, pressure in the bladder on the upper end of the vesical neck and a direct pressure on the vesical neck.

Referring more in detail to the drawings illustrating my invention, Figs. 2 and 3 illustrate the construction of a catheter embodying one form of my invention. While any type of material and construction may be used I prefer that the catheter be made in an integral one piece construction of flexible rubber. The catheter comprises a tubular body portion 10 having a central drainage channel 11 which is closed at the distal end 12. The body portion 10 is provided with one or more openings 13 adjacent the distal end 12 and communicating with the channel 11. Integrally mounted on the body portion 10 and spaced from the distal end is an inflatable balloon portion 14. Mounted on the tubular body 10, slightly spaced from the balloon 14 is a second balloon 15. The balloons 14- and 15 may be made to suit particular requirements. They may be made in identical capacities with varying sizes, or the balloons may each be of a different size and capacity.

In use the balloon 14 is normally positioned in the bladder and the balloon 15 in the prostatic bed. The small space between the balloons is for the vesical neck. Experimentation has shown that the balloons would fall away from each other without applying haemostatic pressure in the desired areas. For the purposes of the present invention I therefore provide an annular membrane 16 extending around the body portion 10 as shown in Fig. 2 and overlapping the adjacent portions of the balloons 14 and 15. The membrane 16 is vulcanized or otherwise attached to the balloons at each end of the membrane. When the balloons are inflated as shown in Fig. 3, the membrane 16 will be stretched and will serve a dual purpose. It will pull the balloons towards each other to exert pressure on the upper and lower portions of the vesical neck and the membrane 16 itself will exert a direct pressure on the vesical neck. By applying pressure to all the affected parts, bleeding should be checked or stopped immediately.

To inflate the balloons, a duct 17 is embedded or formed in the wall of the tubular portion 10 and is provided with an opening 18 communicating with the balloon 14. A second duct 19 is also embedded or formed in the wall of the tubular portion 1% and is provided with an opening 20 communicating with the balloon 15. The rear of the catheter is trifurcated as shown in Fig. 2, the funnel portion 21 communicating with the central drainage channel 11, the funnel portion 22 communicating with the duct 17 and the funnel portion 23 communicating with the duct 19. It is preferable that the balloons 14 and 15 be shaped as illustrated in a general torus shape. However, any other shape may be used. If desired, a single duct may be provided communicating with both balloons so that both balloons will be simultaneously inflated. However, the construction shown permits the pressure in each balloon to be individually varied. In addition, the membrane 16 may be replaced by spaced strips extending between the balloons. Also, the thickness of the membrane 16 may be varied to provide different degrees of elasticity and pressure.

The particular application of the above construction as a haemostatic catheter is illustrated in Fig. l. The general area of the lower male pelvic region comprises a bladder 24, a urethra 25, and a vesical neck 26 which provides the muscular control between the bladder and the urethra. The prostate gland is of generally conical shape and surrounds the urethra just below the vesical neck 26. It is generally enclosed in a bed or sheathe 27 comprising the peri-prostatic tissues. There are several methods of removing the prostate gland. One method is to cut through the front wall of the abdomen and through the wall of the bladder 24. The surgeon then inserts his finger through the vesical neck 26 and peels the prostate gland away from the tissues 27 and removes it. Another method is to make an incision from underneath through the perineum and remove the prostate gland from that direction. In both cases the portion of the urethra which is surrounded by the prostate gland is also torn out. There is thus considerable bleeding at the vesical neck 26 and in the entire surface of the tissues 27.

Referring to Fig. l, the catheter is inserted through the urethra 25 so that the distal end 12 extends into the bladder 24. The catheter is so positioned that the balloon 14 is also within the bladder and the balloon 15 is below the vesical neck. To ensure the proper position ing of the catheter the balloon 14 is inflated first and the catheter pulled downwardly until the balloon 14 rests on the vesical neck. The balloon 15 can then be inflated. The balloons 14 and 15 are inflated by pumping air or water through the ducts 17 and 19 in the conventional manner. As can readily be seen, the balloon 14 will be inflated in the bladder 24 and pressed against the upper end of the vesical neck 26. The balloon 15 will completely fill the cavity formed by the tissues 27 from which the prostate gland was removed and exert a pressure on the walls of the cavity as well as the underside of the vesical neck 26. The membrane 16 will be pulled by the balloons directly against the vesical neck 26. Thus with the balloons inflated direct pressure is brought to bear at every point of bleeding and especially against the vesical neck where most of the bleeding occurs. I

The catheter is locked in place by the inflated balloons and the bladder 24 drains through the opening 13 and the drainage channel 11 in the usual manner. It should be noted that the tissues 27 and muscles will shrink and organize to form a new urethral passageway. However, at this time the area is enlarged and pliable and will take the shape of the balloon 15 as it is inflated. If the catheter is to be used as a conventional drainage catheter, then only one balloon need be inflated.

In removing the prostate gland many veins and arteries are torn and ruptured and there is great danger of bleeding and shock following a prostate operation. The catheter of the present invention is designed to check and prevent these complications. The bleeding is checked almost immediately and the healing is more rapid.

The catheter of the present invention may also be used in other types of operations. For example, in certain lung operations the chest cavity is pierced and drained. A conventional catheter with one balloon is inserted. However, such catheters must be taped so that they will not fall into the chest cavity. The catheter of the present invention can be positioned so that one balloon will inflate inside the cavity and the second one outside the chest. The catheter will then be immovably positioned and will not move either in or out. Furthermore, the pressure of the membrane between the two balloons will prevent any extraneous leakage and all drainage will be through the catheter.

The basic concept of the present invention is the application of a direct pressure on the vesical neck in addition to the pressures normally exerted in the bladder and the prostatic bed. An additional means of accomplishing this result is shown in Figs. 4, and 6. This form of catheter is essentially the same as the form shown in Figs. 2 and 3. The body portion 28 is provided with a central drainage channel 29 closed at the distal end 30. Drainage openings 31 communicate with the channel 29. The balloons 32 and 33 are similar to the balloons 14 and 15 in the first form. As in the first form a connecting membrane 34 straddles the two balloons. The balloon 32 is inflated through a duct 35 terminating in the funnel portion 36. The balloon 33 is inflated through a duct 37 through the funnel portion 38. The funnel 39 connects with the drainage channel 29. However in order to permit the surgeon to exert a greater pressure on the vesical neck, a third duct 40 is formed in the wall of the catheter and is provided with an opening 41 which opens into the space between the balloons 32 and 33. The duct 40 is served by the funnel portion 42.

With the above construction, if water or air is pumped through the duct 40 it will inflate the membrane 34 as shown in Fig. 5. Thus the surgeon will be able to control the pressure at the top of the vesical neck by the inflation of the balloon 33, in the prostatic bed and the bottom of the vesical neck by the inflation of the balloon 32, and at the vesical neck itself by the inflation of the membrane 34. In this form both balloons may also by inflated by a single duct if desired.

In the type of operation referred to, bleeding can be checked if even a light pressure can be brought to bear against the affected surfaces. In the forms illustrated herein, direct pressure can be brought against every portion of the bleeding area. The form shown in Figs. 4, 5 and 6 allows the surgeon to apply additional pressure, if needed, at the point of greatest bleeding.

In either form, the bleeding is checked or stopped immediately by direct pressures on the affected parts, and more particularly on the vesical neck. The catheters are simple in construction and easy to use, either as a haemostatic or as a drainage catheter. Other advantages of the present invention will be readily apparent to a person skilled in the art.

I claim:

1. A surgical accessory comprising an elongated tubular body portion having a central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communicating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, a connecting member extending between the adjacent walls of said balloons spaced from said body portion, said body portion having inflation channels communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels.

2. A surgical accessory comprising an elongated tubular body portion having a central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communicating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, an elastic member extending between the adjacent Walls of said balloons spaced from said body portion, said member comprising an annular elastic membrane having each end anchored to the adjacent balloon wall, said body portion having inflation channels communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels.

3. A surgical accessory comprising an elongated tubular body portion having a central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communieating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, an elastic member extending between the adjacent walls of said balloons spaced from said body portion, said member comprising a plurallty of spaced elastic strips, said body portion having inflation channels communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels.

4. A surgical accessory comprising an elongated tubular body portion'having a, central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communicating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, said balloons being of a generally torus shape, an elastic member extending between the adjacent walls of said balloons spaced from said body portion, said body portion having inflation channels communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels.

5. A surgical accessory comprising an elongated tubular body portion having a central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communicating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, said balloons being of a generally torus shape, an elastic member extending between the adjacent walls of said balloons spaced from said body portion, said member comprising an annular elastic membrane having each end anchored to the adjacent balloon wall, said body portion having inflation channels communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels.

6. A surgical accessory comprising an elongated tubular body portion having a central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communicating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, an elastic member extending between the adjacent walls of said balloons spaced from said body portion, said body portion having inflation channel communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels, and means for applying an inflating pressure to said elastic member.

7. A surgical accessory comprising an elongated tubular body portion having a central longitudinal drainage channel closed at the distal end, said body portion having a drainage opening adjacent the distal end and communicating with said drainage channel, an inflatable balloon on said body portion adjacent the drainage opening, a second inflatable balloon on said body portion slightly spaced from said first balloon, an elastic member extending between the adjacent walls of said balloons spaced from said body portion, said member comprising an annular elastic membrane having each end anchored to the adjacent balloon wall, said body portion having inflation channels communicating with said balloons, and separate conduits at the proximal end of said body portion for said drainage channel and said inflation channels, and means for applying an inflating pressure to said membrane.

8. A haemostatic catheter for stopping bleeding in the vesical neck and in the prostate bed after a prostatectomy, said catheter comprising a tubular body portion adapted to extend through the urethra and vesical neck to a point within the bladder, the walls of said body portion having an opening adjacent the distal end, integral means on said body portion for applying pressure to the lower end of the bladder and the upper end of the vesical neck, integral means on said body portion for applying pressure to the prostate bed and the lower end of the vesical neck, and

means connecting said upper and lower means for applying pressure directly on the vesical neck.

9. A haemostatic catheter for stopping bleeding in the vesical neck and in the prostate bed after a prostatectomy,

said cathetercomprising a tubular body portion adapted to extend through the urethra and vesical neck to a point within the bladder, the walls of said body portion having an opening adjacent the distal end, integral inflatable means on said body portion for applying pressure to the lower end of the bladder and the upper end of the vesical neck, integral inflatable means on said body portion for applying pressure to the prostate bed and the lower end of the vesical neck, and means connecting said upper and lower means for applying pressure directly on the vesical neck.

10. A haemostatic catheter for stopping bleeding in the vesical neck and in the prostate bed after a prostatectomy, said catheter comprising a tubular body portion adapted to extend through the urethra and vesical neck to a point Within the bladder, the walls of said body portion having an opening adjacent the distal end, integral inflatable means on said body portion for applying pressure to the lower end of the bladder and the upper end of the vesical neck, integral inflatable means on said body portion for applying pressure to the prostate bed and the lower end of the vesical neck, and inflatable means connecting said upper and lower means for applying pressure directly on the vesical neck.

11. A haemostatic catheter for stopping bleeding in the vesical neck and in the prostate bed after a prostatectomy, said catheter comprising an elongated tubular body portion adapted to extend through the urethra and vesical neck to a point within the bladder, an inflatable balloon encircling said body portion at a point adjacent the distal end and adapted to be positioned within the bladder and exerting a haemostatic pressure on the bottom of the bladder and the top of the vesical neck, a second inflatable balloon encircling said body portion slightly spaced from said first balloon and adapted to be positioned within the prostate bed and exerting a haemostatic pressure on the bottom of the vesical neck and the Walls of the prostate bed, an elastic membrane connecting the adjacent walls of said balloons, and exerting a haemostatic pressure directly on the vesical neck, the walls of said catheter having a plurality of drainage openings distal to both balloons, a pair of inflating ducts extending longitudinally through the walls of said body portion each communicating with one of said balloons, and a separate tubular extension at the proximal end of said body portion for said body portion and said inflating ducts, said catheter having an integral one-piece flexible rubber construction.

12. A haemostatic catheter for stopping bleeding in the vesical neck and in the prostate bed after a prostatectomy, said catheter comprising an elongated tubular body portion adapted to extend through the urethra and vesical neck to a point within the bladder, an inflatable balloon encircling said body portion at a point adjacent the distal end and adapted to be positioned within the bladder and exerting a haemostatic pressure on the bottom of the bladder and the top of the vesical neck, a second inflatable balloon encircling said body portion slightly spaced from said first balloon and adapted to be positioned within the prostate bed and exerting a haemostatic pressure on the bottom of the vesical neck and the walls of the prostate bed, the walls of said catheter having a plurality of drainage openings distal to both balloons, a pair of inflating ducts extending longitudinally through the walls of said body portion each communicating with one of said balloons, a third inflating duct communicating with the space between said balloons beneath said membrane, and a separate tubular extension at the proximal end of said body portion for said body portion and said inflating ducts, said catheter having an integral one-piece flexible rubber construction.

(References on following page) 8 Keeling June 23, 1953 Raiche Nov. 2, 1954 References Cited in the file of this patent UNITED STATES PATENTS 550,238 Allen Nov. 26, 1895 1,598,284 Kinny Aug. 31, 1926 OTHER REFERENCES 2,547,758 Keeling Apr. 3, 1951 The Foley Haemostatic Bag and Catheter from Surgery, 2,610,626 Edwards Sept. 16, 1952 Gynecology and Obstetrics, Feb. 1, 1937; page 12. 

